💬In plain words
What the trial is, and whether it could suit you
This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Adults (aged 18-65 years)
* Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21
* Currently experiencing depression (i.e., PHQ-9 ≥ 10)22
* Currently overweight (i.e., Body mass index (BMI) \> 30 kg/m2)
* Provides Informed Consent
Exclusion Criteria:
1. Dietary factors:
1. Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID)
2. Concurrent dietary intervention or modification unrelated to study procedures
2. Psychiatric factors:
1. Severe depression (i.e., PHQ-9\>20)
2. Experiencing manic symptoms (i.e., ASRM \< 6)23
3. Active suicidal ideation (i.e., PHQ-9, item 9 \>2)
4. Current alcohol/substance use disorder (as assessed with the Quick SCID)
3. Medical factors:
1. Use of weight loss medications or supplements
2. Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
3. Previous weight loss surgery
4. Malignancy within past 2 years
5. Major surgery within past 3 months
6. Medical instability considered to interfere with study procedures
7. Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)
8. Undergoing treatment for cancer
9. Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake.
4. Lifestyle and other factors:
a. Work or social schedules that would impede ability to adhere to study protocol
5. Adherence factors:
1. Ability to adhere to study procedures
Massachusetts General Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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